1. Field of the Invention
Disclosed is a device and method for performing needle guided interventions and especially needle guided dilations of tissue to create a therapeutic conduit between two luminal organs or structures. The device is particularly useful for creation of an artificial lumen between hollow body organs using the working lumen of an endoscope.
2. Description of the Related Art
Often there is a need to create a luminal passageway between two lumen containing organs in the body. Examples of these would be between a segment of bowel and another structure such as another section of bowel, gallbladder, bile or pancreatic duct. Often the second luminal structure is not an organ but rather a cyst, pseudocyst or abscess.
Other techniques and devices exist to perform these procedures. The creation of a conduit between a bowel lumen (stomach, colon, rectum or duodenum) and a luminal structure is performed using an ultrasound endoscope. A stylet-filled continuous stainless steel needle is advanced through the working lumen of an ultrasound endoscope and directed through the wall of the bowel and into the targeted luminal structure lying adjacent to the bowel. Once inside the structure the stylet is removed and a guidewire is advanced into the luminal structure. The needle is removed and a catheter device is advanced over the guidewire and directed through the bowel wall into the luminal structure. Examples of catheter devices are dilating bougie catheters and balloon catheters.
One example of how these procedures are typically performed is the drainage of fluid from a pseudocyst. In this procedure a stylet-filled continuous stainless steel needle is advanced through the working lumen of an endoscope and directed through the wall of the bowel and into a pseudocyst cavity lying adjacent to the bowel. Once inside the cavity, the stylet is removed and a guidewire is advanced through the needle and into the pseudocyst. The needle is removed and a balloon catheter is advanced over the guidewire and directed through the bowel wall until the deflated balloon lies across the wall of the bowel and the tissue interposed between the bowel and the pseudocyst. The balloon is then inflated creating a 6-8 mm passageway between the bowel and the pseudocyst cavity. The balloon is deflated and the catheter removed over the guidewire leaving behind an enlarged conduit. A double pigtailed drainage catheter or other drainage device is then advanced over the guidewire and one end is placed inside the pseudocyst cavity and the other inside the bowel thus facilitating the drainage of fluid from the pseudocyst into the bowel.
Another example of how these procedures are typically performed is the creation of a conduit between an obstructed bile or pancreatic duct and a bowel lumen using an ultrasound endoscope. A stylet-filled continuous stainless steel needle is advanced through the working lumen of an ultrasound endoscope and directed into the bile or pancreatic duct upstream from the site of obstruction. Once inside the duct, the stylet is removed and a guidewire is advanced through the needle and into the duct. The needle is removed and a dilating catheter or balloon catheter is advanced over the guidewire and directed into the duct. A stent is then advanced over the guidewire and one end is placed inside the duct and the other inside the bowel.
However the procedures as described above are often difficult to complete successfully because once the needle is removed, the remaining guidewire lacks the rigidity to provide adequate support for the catheter device. This makes it difficult to push the catheter device through the bowel wall and into the luminal structure. This is particularly true when the tissue interposed between the bowel lumen and the targeted luminal structure is thick, edematous or fibrotic. Often the catheter device will simply buckle inside the bowel and not advance through the wall. Furthermore, the small diameter guidewire has a tendency to dislodge during the exchange of the needle for the balloon catheter which causes a loss of lumen access and necessitates repeating the procedure. Even when successful, the physician is required to make many exchanges of the needle, guidewire and or catheters which can make the technique cumbersome and time consuming. A simpler procedure is necessary to overcome the disadvantages of current practice. Particularly, a system that will enable rapid catheter device access on the initial attempt after needle puncture of the target luminal structure and one that does not require multiple exchanges of accessories is needed. Also needed is a method of fixing the position of the needle and catheter device sheath relative to the endoscope while one or the other is advanced or retracted. Particularly, providing a more stable platform over which a catheter device sheath may be advanced is important and incorporating all the wires, sheaths and needles into a single integrated system would save the practitioner valuable time and reduce the chance of potential surgical morbidity.